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[Federal Register Volume 77, Number 247 (Wednesday, December 26, 2012)]
[Proposed Rules]
[Pages 75936-75939]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-30726]

[[Page 75936]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

42 CFR Part 70

[Docket No. CDC-2012-0016]
RIN 0920-AA22

Control of Communicable Diseases: Interstate; Scope and 
Definitions

AGENCY: Centers for Disease Control and Prevention (HHS/CDC), 
Department of Health and Human Services (HHS).

ACTION: Notice of Proposed Rulemaking and request for comments.

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SUMMARY: In this Notice of Proposed Rulemaking (NPRM), the Centers for 
Disease Control and Prevention (CDC), located within the Department of 
Health and Human Services (HHS) is proposing to update the definitions 
for interstate quarantine regulations to reflect modern terminology and 
plain language used by private industry and public health partners. 
These updates will not affect current practices. As part of the update, 
we are updating two existing definitions and adding eight new 
definitions to clarify existing provisions, as well as updating 
regulations to reflect the most recent Executive Order addressing 
quarantinable communicable diseases.

DATES: Submit written or electronic comments by January 25, 2013.

ADDRESSES: You may submit comments, identified by ``RIN 0920-AA22'': By 
any of the following methods:
     Internet: Access the Federal e-rulemaking portal at http://www.regulations.gov. Follow the instructions for submitting comments.
     Mail: Division of Global Migration and Quarantine, Centers 
for Disease Control and Prevention, 1600 Clifton Road NE., MS-03, 
Atlanta, Georgia 30333, ATTN: Part 70 NPRM.
    Instructions: All submissions received must include the agency name 
and docket number or Regulation Identifier Number (RIN) for this 
rulemaking. All relevant comments will be posted without change to 
http://regulations.gov, including any personal information provided. 
For detailed instructions on submitting comments and additional 
information on the rulemaking process, see the ``Public Participation'' 
heading of the SUPPLEMENTARY INFORMATION section of this document.
    Docket: For access to the docket to read background documents or 
comments received, please go to http://www.regulations.gov. Comments 
will be available for public inspection Monday through Friday, except 
for legal holidays, from 9 a.m. until 5 p.m., Eastern Time, at 1600 
Clifton Road NE., Atlanta, Georgia 30333. Please call ahead to 1-866-
694-4867 and ask for a representative in the Division of Global 
Migration and Quarantine (DGMQ) to schedule your visit. To download an 
electronic version of the rule, access http://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: For questions concerning this notice 
of proposed rulemaking: Ashley A. Marrone, JD, Centers for Disease 
Control and Prevention, 1600 Clifton Road NE., Mailstop E-03, Atlanta, 
Georgia 30333; telephone 404-498-1600.

SUPPLEMENTARY INFORMATION: HHS/CDC is simultaneously publishing a 
companion direct final rule (DFR) in the Federal Register that proposes 
identical updates because we believe that these requirements are non-
controversial and unlikely to generate significant adverse comment. If 
HHS/CDC does not receive any significant adverse comments on the DFR 
within the specified comment period, we will publish a document in the 
Federal Register withdrawing this NPRM and confirming the effective 
date of the DFR within 30 days after the comment period on the DFR 
ends. If HHS/CDC receives any timely significant adverse comment, we 
will withdraw the DFR in part or in whole by publication of a document 
in the Federal Register within 30 days after the comment period. HHS/
CDC will carefully consider all public comments received before 
proceeding with any subsequent final rule based on the NPRM. A 
significant adverse comment is one that explains: (1) Why the DFR is 
inappropriate, including challenges to the rule's underlying premise or 
approach; or (2) why the DFR will be ineffective or unacceptable 
without a change.
    This preamble is organized as follows:

I. Public Participation
II. Authority for These Regulations
III. Proposed Updates to Section 70.1
    A. Definitions Updated Under Section 70.1
    B. Definitions Added to Section 70.1
IV. Proposed Update to Section 70.6
V. Alternative Considered
VI. Required Regulatory Analyses
    A. Required Regulatory Analyses Under Executive Orders 12866 and 
13563
    B. Regulatory Flexibility Act
    C. Small Business Regulatory Enforcement Fairness Act of 1996
    D. The Paperwork Reduction Act of 1995
    E. National Environmental Policy Act (NEPA)
    F. Civil Justice Reform (Executive Order 12988)
    G. Executive Order 13132 (Federalism)
    H. Plain Language Act of 2010

I. Public Participation

    Interested persons are invited to participate in this rulemaking by 
submitting written views, opinions, recommendations, and data. Comments 
received, including attachments and other supporting materials, are 
part of the public record and subject to public disclosure. Do not 
include any information in your comment or supporting materials that 
you do not wish to be disclosed publicly. Comments are invited on any 
topic related to this NPRM.

II. Authority for These Regulations

    The primary authority supporting this rulemaking is section 361 of 
the Public Health Service Act (42 U.S.C. 264). Section 361 authorizes 
the Secretary of HHS to make and enforce regulations as in the 
Secretary's judgment are necessary to prevent the introduction, 
transmission, or spread of communicable diseases from foreign countries 
into the states or possessions of the United States and from one state 
or possession into any other state or possession. Regulations that 
implement federal quarantine authority are currently promulgated in 42 
CFR Parts 70 and 71. Part 71 contains regulations to prevent the 
introduction, transmission, and spread of communicable diseases into 
the states and possessions of the United States, while Part 70 contains 
regulations to prevent the introduction, transmission, or spread of 
communicable diseases from one state into another. The Secretary has 
delegated to the Director of the Centers for Disease Control and 
Prevention the authority for implementing these regulations.
    Authority for carrying out most of these functions has been 
delegated to HHS/CDC's Division of Global Migration and Quarantine 
(DGMQ). The Secretary's authority to apprehend, examine, detain, and 
conditionally release individuals is limited to those quarantinable 
communicable diseases published in an Executive Order of the President. 
This list currently includes cholera, diphtheria, infectious 
tuberculosis (TB), plague, smallpox, yellow fever, and viral 
hemorrhagic fevers, such as Marburg, Ebola, and Crimean-Congo 
hemorrhagic fever (CCHF), Severe Acute Respiratory Syndrome (SARS), and 
influenza caused by novel or re-emergent influenza viruses that are 
causing or have the potential to cause a pandemic (see Executive Order 
13295, as amended by Executive Order 13375 on April 1, 2005).

[[Page 75937]]

III. Proposed Updates to Section 70.1

    Regulations that implement federal authority for interstate 
quarantine are currently promulgated in 42 CFR part 70. The Secretary 
of HHS has delegated to the Director of the Centers for Disease Control 
and Prevention the authority for implementing 42 CFR part 70.
    Through this NPRM, HHS/CDC proposes to update the Definitions for 
42 CFR part 70, under section 70.1, to reflect modern terminology and 
plain language commonly used by private sector industry and public 
health partners, as well as clarify the intent of the provisions that 
follow. Specifically, we are proposing to update two existing 
definitions, add eight new definitions to clarify existing provisions, 
and update 70.6 to reflect the language of the most recent Executive 
Order concerning quarantinable communicable diseases.
    Section 70.1 (b) contains the definitions used in this NPRM. The 
NPRM proposes new or updated definitions to be consistent with modern 
quarantine concepts and current medical and public health principles 
and practice. Table 1 lists the current definitions found in the 42 CFR 
part 70 and the definitions proposed in this NPRM.

  Table 1--Definitions and Corresponding Changes in Definitions in the
                               Final Rule
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                                                Corresponding, new or
  Existing definitions in  42 CFR Part 70    updated definition in NPRM
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                                            CDC.
Communicable diseases.....................  No Change.
Communicable period.......................  No Change.
                                            Conditional release.
Conveyance................................  No Change.
                                            Director.
Incubation period.........................  No Change.
Interstate traffic........................  No Change.
                                            Isolation.
                                            Master or Operator.
Possession................................  Updated.
                                            Quarantine.
                                            Quarantinable communicable
                                             disease.
State.....................................  Updated.
                                            U.S. Territory.
Vessel....................................  No Change.
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A. Definitions Updated Under Section 70.1

    Possession. To best add clarity to Part 70, we propose to update 
the term ``possession'' to mean ``U.S. Territory'' and propose to 
define U.S. Territory to include American Samoa, Guam, the Commonwealth 
of the Northern Mariana Islands, the Commonwealth of Puerto Rico, and 
the U.S. Virgin Islands. Currently, only Puerto Rico and the Virgin 
Islands are explicitly listed in the definition. Thus, CDC is updating 
this provision to explicitly list the other U.S. jurisdictions to which 
this part applies.
    State. To best add clarity to the regulations of Part 70, 
specifically where roles and responsibilities are outlined, we propose 
to include a definition of ``state'' to mean any of the 50 states 
within the United States, plus the District of Columbia.

B. Definitions Added to Part 70.1

    CDC. We proposed to define ``CDC'' to mean the Centers for Disease 
Control and Prevention within the Department of Health and Human 
Services to clarify the provisions under Part 70.
    Conditional release. We propose to define ``conditional release'' 
to have the same meaning as ``surveillance,'' as that term is defined 
in the NPRM for updates to 42 CFR Sec.  71.1. We have included this 
definition to best add clarity to the provisions and practices under 
Part 70, specifically section 70.6 as well as ensure that conditional 
release and surveillance are both used consistently in both Parts 70 
and 71.
    Director. To clarify the provisions under Part 70, we propose to 
define ``Director'' to mean the Director, Centers for Disease Control 
and Prevention, Department of Health and Human Services, or another 
authorized representative as approved by the CDC Director or the 
Secretary of HHS.
    Isolation. We are proposing to separately define ``isolation'' as 
the separation of an individual or group reasonably believed to be 
infected with a quarantinable communicable disease from those who are 
healthy to prevent the spread of the quarantinable communicable 
disease. This NPRM clarifies the distinction between quarantine and 
isolation by separately defining ``quarantine'' and ``isolation'' to 
distinguish these common public health measures. Isolation as currently 
used in 42 CFR 71.1 applies to both persons and groups of persons. 
Thus, CDC is changing the definition in Part 70 so that the term is 
used consistently in both Part 70 and 71. Applying isolation measures 
to groups of individuals is consistent with CDC's current practice and 
does not constitute a substantive change.
    ``Master'' or ``Operator''. We are proposing to define ``Master'' 
or ``Operator'' as the aircrew or sea crew member with responsibility 
respectively for aircraft or vessel operation and navigation or a 
similar individual with responsibility for a conveyance. We have 
included this definition to better identify and assign responsibilities 
under this subpart (according to current practices).
    Quarantine. We are proposing to define ``quarantine'' as the 
separation of an individual or group reasonably believed to have been 
exposed to a quarantinable communicable disease, but who is not yet 
ill, from others who have not been so exposed, to prevent the possible 
spread of the quarantinable communicable disease. In this NPRM, HHS/CDC 
is separately defining quarantine and isolation to distinguish these 
common public health measures. Applying quarantine measures to groups 
of individuals is consistent with HHS/CDC's current practice and does 
not constitute a substantive change.
    Quarantinable communicable disease. Under the proposed definition, 
``quarantinable communicable disease'' means any of the communicable 
diseases listed in an Executive Order, as provided under section 361 of 
the Public Health Service Act (42 U.S.C. 264). Executive Order 13295, 
of April 4, 2003, as amended by Executive Order 13375 of April 1, 2005, 
contains the current revised list of quarantinable communicable 
diseases, and may be found at http://www.cdc.gov/quarantine and in the 
docket as supplemental documents. If this Executive Order is amended, 
HHS/CDC will enforce the amended order immediately and update its Web 
site. The proposed definition for ``quarantinable communicable 
disease'' is being added to Part 70 through this NPRM to reflect the 
most recent Executive Order regarding quarantinable communicable 
diseases. This addition does not reflect a substantive change from 
current practice.
    U.S. Territory. We are proposing to define ``U.S. Territory'' to 
mean any territory (also known as possessions) of the United States 
including American Samoa, Guam, the Commonwealth of the Northern 
Mariana Islands, the Commonwealth of Puerto Rico, and the U.S. Virgin 
Islands. The Department of the Interior's Office of Insular Affairs, 
the federal government's cognizant agency for U.S. territories, no 
longer uses the term ``possession'' to refer to these jurisdictions. 
Consequently, HHS/CDC is adding a new definition for U.S. territory 
consistent with current federal usage.

IV. Proposed Update to Section 70.6

    Section 70.6, Apprehension and detention of persons with specific 
diseases, contains the general authority for the Director to take 
measures with respect to persons to protect the public's health against 
the spread of communicable diseases ``listed in an

[[Page 75938]]

Executive Order setting out a list of quarantinable communicable 
diseases, as provided under section 361(b) of the Public Health Service 
Act.'' The current section 71.32(a) lists Executive Order 13295, of 
April 4, 2003. The subpart states that ``If this Order is amended, HHS 
will enforce that amended order.'' On April 1, 2005, this Executive 
Order was amended by Executive Order 13375. Therefore, as part of the 
non-controversial changes in this NPRM, we are also proposing to update 
section 70.6 to reflect the most recent amendment to the Executive 
Order which lists the ``quarantinable communicable disease,'' which we 
have also defined. These proposed changes are not substantive and will 
not affect current practices.

V. Alternatives Considered

    Under Executive Order 13563 agencies are asked to consider all 
feasible alternatives to current practice and the rule as proposed. 
HHS/CDC notes that the main impact of this proposed rule is to update 
current definitions and clarify language in the current regulation to 
reflect modern terminology and plain language commonly used by global 
private sector industry and public health partners. The intent of these 
updates is to clarify the provisions of the existing regulation to help 
the regulated community comply with current regulation and protect 
public health. HHS/CDC believes that this rulemaking complies with the 
spirit of the Executive Order; updating current definitions, clarifying 
language, and updating the referenced Executive Order provides good 
alternatives to the current regulation.

VI. Required Regulatory Analyses

A. Required Regulatory Analyses Under Executive Orders 12866 and 13563

    Under Executive Order 12866 (EO 12866), Regulatory Planning and 
Review (58 FR 51735, October 4, 1993) HHS/CDC is required to determine 
whether this regulatory action would be ``significant'' and therefore 
subject to review by the Office of Management and Budget (OMB) and the 
requirements of the Executive Orders. This order defines ``significant 
regulatory action'' as any regulatory action that is likely to result 
in a rule that may:
     Have an annual effect on the economy of $100 million or 
more or adversely affect in a material way the economy, a sector of the 
economy, productivity, competition, jobs, the environment, public 
health or safety, or state, local, or tribal governments or 
communities;
     Create a serious inconsistency or otherwise interfere with 
an action taken or planned by another agency;
     Materially alter the budgetary impact of entitlements, 
grants, user fees, or loan programs or the rights and obligations of 
recipients; or,
     Raise novel legal or policy issues arising out of legal 
mandates, the President's priorities, or the principles set forth in EO 
12866.
    Executive Order 13563 (EO 13563), Improving Regulation and 
Regulatory Review, (76 FR 3821, January 21, 2011), updates some of the 
provisions of EO 12866 in order to promote more streamlined regulatory 
actions. This EO charges, in part, that, while protecting ``public 
health, welfare, safety, and our environment'' that regulations must 
also ``promote predictability and reduce uncertainty'' in order to 
promote economic growth. Further, regulations must be written in common 
language and be easy to understand. In the spirit of EO 13563, we 
propose to enhance definitions related to the control of communicable 
diseases and add more current medical terminology where appropriate.
    HHS/CDC has determined that this NPRM is simply an update and 
clarification of definitions and terms used in the current regulation. 
As such, the NPRPM complies with the spirit of EO 13563. Further, HHS/
CDC has determined that this NPRM is not a significant regulatory 
action as defined in EO 12866 because the NPRM is definitional and does 
not change the baseline costs for any of the primary stakeholders.

B. Regulatory Flexibility Act

    We have examined the impacts of the rule under the Regulatory 
Flexibility Act (5 U.S.C. 601-612). Unless we certify that the rule is 
not expected to have a significant economic impact on a substantial 
number of small entities, the Regulatory Flexibility Act (RFA), as 
amended by the Small Business Regulatory Enforcement Fairness Act 
(SBREFA), requires agencies to analyze regulatory options that would 
minimize any significant economic impact of a rule on small entities. 
We certify that this proposed rule will not have a significant economic 
impact on a substantial number of small entities within the meaning of 
the RFA.

C. Small Business Regulatory Enforcement Fairness Act of 1996

    This proposed rule is not a major rule as defined by Sec. 804 of 
the Small Business Regulatory Enforcement Fairness Act of 1996. This 
rule will not result in an annual effect on the economy of $100,000,000 
or more; a major increase in cost or prices; or significant adverse 
effects on competition, employment, investment, productivity, 
innovation, or on the ability of United States-based companies to 
compete with foreign-based companies in domestic and export markets.

D. The Paperwork Reduction Act of 1995

    HHS/CDC has already determined that the Paperwork Reduction Act 
applies to the data collection and record keeping requirements of 42 
CFR Part 70 and has obtained approval by the Office of Management and 
Budget (OMB) to collect data and require record keeping under OMB 
Control No. 0920-0488, expiration 03/31/2013. The changes proposed in 
this rule do not impact the data collection or record keeping 
requirements and do not require revision to the approval from OMB.

E. National Environmental Policy Act (NEPA)

    Pursuant to 48 FR 9374 (list of HHS/CDC program actions that are 
categorically excluded from the NEPA environmental review process), 
HHS/CDC has determined that this action does not qualify for a 
categorical exclusion. In the absence of an applicable categorical 
exclusion, the Director, CDC, has determined that provisions proposing 
to amending 42 CFR Part 70 will not have a significant impact on the 
human environment. Therefore, neither an environmental assessment nor 
an environmental impact statement is required.

F. Civil Justice Reform (Executive Order 12988)

    This proposed rule has been reviewed under Executive Order 12988, 
Civil Justice Reform. Under this rule: (1) All state and local laws and 
regulations that are inconsistent with this rule will be preempted; (2) 
no retroactive effect will be given to this rule; and (3) 
administrative proceedings will not be required before parties may file 
suit in court challenging this rule.

G. Executive Order 13132 (Federalism)

    HHS/CDC has reviewed this proposed rule in accordance with 
Executive Order 13132 regarding Federalism, and has determined that it 
does not have ``federalism implications.'' The proposed rule does not 
``have substantial direct effects on the States, on the relationship 
between the national government and the States, or on the distribution 
of power and

[[Page 75939]]

responsibilities among the various levels of government.''

H. Plain Language Act of 2010

    Under Public Law 111-274 (October 13, 2010), executive Departments 
and Agencies are required to use plain language in documents that 
explain to the public how to comply with a requirement the Federal 
Government administers or enforces. HHS/CDC has attempted to use plain 
language in promulgating this rule consistent with the Federal Plain 
Writing Act and requests public comment on this effort.

List of Subjects in 42 CFR Part 70

    Communicable diseases, CDC, Isolation, Public health, Quarantine, 
Quarantinable Communicable Disease.

Proposed Text

    For the reasons discussed in the preamble, the Centers for Disease 
Control and Prevention proposes to amend 42 CFR part 70 as follows:

PART 70--INTERSTATE QUARANTINE

    1. The authority citation for part 70 continues to read as follows:

    Authority: Secs. 215 and 311 of the Public Health Service (PHS) 
Act, as amended (42 U.S.C. 216, 243); section 361-369, PHS Act, as 
amended (42 U.S.C. 264-272); 31 U.S.C. 9701.

    2. Amend Sec.  70.1 as follows:
    a. Remove paragraph designations (a), (b), (c), (d), (e), (f), and 
(g).
    b. Add in alphabetical order definitions of CDC, Conditional 
release, Director, Isolation, Master or Operator, Quarantine, 
Quarantinable communicable disease, and U.S. Territory.
    c. Revise the definitions of Possession and State. The revisions 
and additions read as follows:

Sec.  70.1  General definitions.

* * * * *
    CDC means the Centers for Disease Control and Prevention, 
Department of Health and Human Services.
* * * * *
    Conditional release means ``surveillance'' as that term is defined 
in 42 CFR 71.1.
* * * * *
    Director means the Director, Centers for Disease Control and 
Prevention, Department of Health and Human Services, or another 
authorized representative as approved by the CDC Director or the 
Secretary of HHS.
* * * * *
    Isolation means the separation of an individual or group reasonably 
believed to be infected with a quarantinable communicable disease from 
those who are healthy to prevent the spread of the quarantinable 
communicable disease.
    Master or Operator means the aircrew or sea crew member with 
responsibility respectively for aircraft or vessel operation and 
navigation, or a similar individual with responsibility for a 
conveyance.
    Possession means U.S. Territory.
    Quarantine means the separation of an individual or group 
reasonably believed to have been exposed to a quarantinable 
communicable disease, but who are not yet ill, from others who have not 
been so exposed, to prevent the possible spread of the quarantinable 
communicable disease.
    Quarantinable communicable disease means any of the communicable 
diseases listed in an Executive Order, as provided under section 361 of 
the Public Health Service Act. Executive Order 13295, of April 4, 2003, 
as amended by Executive Order 13375 of April 1, 2005, contains the 
current revised list of quarantinable communicable diseases, and may be 
obtained at http://www.cdc.gov and http://www.archives.gov/federal_register. If this Order is amended, HHS will enforce that amended order 
immediately and update that Web site.
    State means any of the 50 states, plus the District of Columbia.
    U.S. Territory means any territory (also known as possessions) of 
the United States, including American Samoa, Guam, the Northern Mariana 
Islands, the Commonwealth of Puerto Rico, and the U.S. Virgin Islands.
* * * * *
    3. Revise Sec.  70.6 to read as follows:

Sec.  70.6  Apprehension and detention of persons with specific 
diseases.

    Regulations prescribed in this part authorize the detention, 
isolation, quarantine, or conditional release of individuals, for the 
purpose of preventing the introduction, transmission, and spread of the 
communicable diseases listed in an Executive Order setting out a list 
of quarantinable communicable diseases, as provided under section 
361(b) of the Public Health Service Act. Executive Order 13295, of 
April 4, 2003, as amended by Executive Order 13375 of April 1, 2005, 
contains the current revised list of quarantinable communicable 
diseases, and may be obtained at http://www.cdc.gov/quarantine and 
http://www.archives.gov/federal_register. If this Order is amended, 
HHS will enforce that amended order immediately and update its Web 
site.

    Dated: December 13, 2012.
Kathleen Sebelius,
Secretary, Department of Health and Human Services.
[FR Doc. 2012-30726 Filed 12-21-12; 4:15 pm]
BILLING CODE 4163-18-P
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